UTHR Holds As Tyvaso Shows 33% Lower Worsening Risk In Rare Lung Scarring Disease

• When researchers combined results from two similar studies, the benefits were consistent: better lung function, fewer disease flare-ups, and improved quality of life, United said. 
• Tyvaso is already approved for a different lung condition, but it is still considered experimental for idiopathic pulmonary fibrosis.
• The company plans to ask the FDA for priority review of an expanded approval by the end of this summer.

United Therapeutics (UTHR) on Monday announced positive late-stage trial results that showed its inhaled drug Tyvaso helped patients with idiopathic pulmonary fibrosis (IPF) — a rare, progressive lung-scarring disease.

The TETON-1 study found that nebulized Tyvaso helped patients preserve significantly more lung function after one year compared with placebo. Patients taking the drug also had a 33% lower risk of their condition worsening. When researchers combined results from two similar studies, the benefits were consistent: better lung function, fewer disease flare-ups, and improved quality of life. The positive effects appeared across different patient groups, including those already taking other approved IPF medicines. The full results were published in The New England Journal of Medicine and presented at a leading medical conference.

Tyvaso Approvals

The drug was generally well-tolerated with no new safety concerns reported. Tyvaso is already approved for a different lung condition, but it is still considered experimental for idiopathic pulmonary fibrosis.

“This represents a truly important advancement for people living with this progressive, life-threatening disease,” said Martine Rothblatt, chairperson and chief executive officer of United Therapeutics.

The company plans to ask the FDA for priority review of an expanded approval by the end of this summer. If granted, Tyvaso could become the first new treatment option in years for patients with this form of lung fibrosis.

United Therapeutics owns Tyvaso and holds all global development, regulatory, and commercial rights to the drug. MannKind Corporation is a manufacturing partner, supplying the dry-powder version using its Technosphere technology and earning royalties on sales.

How Did UTHR Retail Traders React?

On Stocktwits, retail sentiment around UTHR stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.  

UTHR has gained about 86% over the past 12 months.  

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